ADaM

Analysis Data Model

CDISC model for analysis datasets.

AE

Adverse Event

Safety event captured on eCRFs per protocol.

ALCOA+

Attributable, Legible, Contemporaneous, Original, Accurate (+Complete, Consistent, Enduring, Available, Traceable)

Data integrity principles.

BAA

Business Associate Agreement

HIPAA-required contract with a vendor/partner handling PHI; defines responsibilities for safeguarding, permitted uses, and breach notification. See also: DUA, DHA, DTA.

CAPA

Corrective and Preventive Action

Quality process used to address protocol deviations/violations or audit findings; documents root cause, corrective steps, and preventive measures to avoid recurrence.

CCHMC

Cincinnati Children’s Hospital Medical Center

Academic pediatric medical center; home of the DMCC and partner departments.

CFR

Code of Federal Regulations

e.g., 21 CFR Part 11 (e-records), 45 CFR 46 (human subjects).

CDASH

Clinical Data Acquisition Standards Harmonization

CDISC standard for designing CRFs/eCRFs and data-collection fields; aligns with SDTM.

CDISC

Clinical Data Interchange Standards Consortium

SDTM, ADaM, Define-XML, etc.

CPAG

Coalition of Patient Advocacy Groups

Patient advocacy arm of RDCRN; unites all consortium PAGs into a collaborative group where they are encouraged to co-develop and access tools helpful along their path toward clinical trial readiness.

CRC

Clinical Research Coordinator

Coordinates day-to-day study conduct: visits, consent support, data entry, query resolution.

CRF

Case Report Form

Structured data collection; “eCRF” in EDC (e.g., REDCap). Design via CDASH; trace to protocol endpoints.

CRO

Contract Research Organization

External vendor for trial operations.

CSV

Comma-separated values

File type for importing and exporting REDCap data

DAG

Data Access Group: Who has access to view a record in REDCap, typically a clinical site or PI

REDCap feature isolating records by group/site; prevents cross-site viewing; membership assigned per user.

DBE

Division of Biostatistics and Epidemiology at CCHMC

CCHMC group partnering on design, analysis, reporting, and methods support.

DC

Data Coordinator

Supports the Data Manager (DM) by handling day-to-day operational tasks (e.g., data entry oversight, queries); ensures smooth execution under DM guidance.

DCC

Data Coordinating Center

Synonym/near to DMCC depending on use.

DHA

Data Hosting Agreement

Defines hosting responsibilities (platform, security, backups, uptime) when a vendor hosts study data; often paired with a BAA if PHI is involved. See also: BAA, DUA, DTA.

DM

Data Manager

Leads the study’s data management activities; responsible for overall data quality, standards, and compliance. Provides oversight and direction to the Data Coordinator (DC).

DMAC

Data Management & Analysis Collaborative

CCHMC internal group supporting DMCC.

DMCC

Data Management & Coordinating Center

RDCRN central hub for data standards, quality, reporting, multi-site coordination, and RDCRN operations coordinating hub.

DMP

Data Management Plan

Study-level plan for data processes.

DQP

Data Quality Plan

Study-level plan outlining data quality expectations, edit checks, review procedures, and responsibilities; supports compliance and database lock readiness.

DSMB

Data and Safety Monitoring Board

Independent committee that reviews accumulating study data for safety and efficacy; provides recommendations on continuation, modification, or termination of the trial.

DTA/DTS

Data Transfer Agreement/Specifications

Governs secure transfer of study data between parties (format, cadence, encryption, contacts, responsibilities); may be paired with a BAA if PHI is transferred. See also: BAA, DUA, DHA.

DUA

Data Use Agreement

Governs sharing of Limited Data Sets under HIPAA; legal contract defining permitted uses, disclosures, safeguards, and responsibilities. See also: LDS.

EDC

Electronic Data Capture

Primary system for eCRFs.

EDC

Engagement and Dissemination Core

Promotes patient engagement, network collaboration, and research dissemination

eCOA

electronic Clinical Outcome Assessment

Includes ePRO, eDiary, etc.

eCRF

electronic Case Report Form

Digital version of a CRF used within an Electronic Data Capture (EDC) system; ensures structured, validated data entry and traceability to protocol endpoints. See also: CRF.

eICF

electronic Informed Consent Form

Digital implementation of the informed consent process; presented via electronic platforms with features like electronic signatures. See also: ICF.

ePRO

electronic Patient-Reported Outcome

Participant-entered outcomes.

eTMF

electronic Trial Master File

Digital repository of essential trial documents; demonstrates compliance with GCP and regulatory requirements; supports inspection readiness.

FDA

U.S. Food and Drug Administration

Regulator for drugs/devices/biologics.

FOA

Funding Opportunity Announcement

Older NIH/agency term for grant solicitations; replaced by “NOFO” but still used in legacy documents and references.

FPFV

First Patient, First Visit

Study milestone.

GCP

Good Clinical Practice

International ethical and scientific quality standard (ICH E6 (R3)) for designing, conducting, recording, and reporting trials; ensures rights, safety, and data integrity.

GDPR

General Data Protection Regulation

EU data protection; de-identification, rights.

GUID

Global Unique Identifier

De-identified participant code enabling cross-study linkage without sharing PII/PHI.

HHS

U.S. Department of Health and Human Services

HIPAA

Health Insurance Portability and Accountability Act

U.S. health data privacy.

ICH

International Council for Harmonisation

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use | Global standards-setting body; issues guidelines (e.g., E6 (R3) GCP, E3 CSR) harmonizing regulatory expectations across regions.

ICF

Informed Consent Form

Document reviewed and signed by participants (or LARs) before study procedures; approved by IRB/ethics board and updated with protocol amendments. See also: eICF

IRB

Institutional Review Board

Ethics oversight; approve protocol/consent before enrollment; monitor amendments and continuing review.

IRT

Interactive Response Technology

Randomization/dispensing (a.k.a. IWRS/IVRS).

IS4R

Information Services for Research

CCHMC internal group supporting DMCC.

LAR

Legally Authorized Representative

Individual authorized under applicable law to consent on behalf of a participant (e.g., parent/guardian for a minor, proxy for an incapacitated adult).

LDS

Limited Data Set

HIPAA-defined dataset with certain direct identifiers removed (e.g., name, address) but some dates and geographic info retained; requires a Data Use Agreement (DUA). See also: DUA.

LPLV

Last Patient, Last Visit

Study milestone.

MLP

Members Landing Page

The home page (https://members.rarediseasesnetwork.org/home/) for members of the RDCRN once they have authenticated and logged into their account through the public-facing RDCRN website (https://www.rarediseasesnetwork.org/ )

MOO

Manual of Operations

Program/network operations playbook—roles, workflows, communications; complements study-level MOP.

MOP

Manual of Procedures

Study/site procedures manual—visit schedules, data collection, deviations, and query/lock workflows.

NIH

National Institutes of Health

U.S. biomedical research agency (HHS); funds grants and sets research policy.

NCATS

National Center for Advancing Translational Sciences

Steward of RDCRN; accelerates translation and supports rare-disease networks.

NHLBI

National Heart, Lung, and Blood Institute

Heart, lung, and blood diseases; multi-center trials and data commons.

NIAID

National Institute of Allergy and Infectious Diseases

Immunology/infectious disease research; clinical trials in vaccines and therapeutics.

NIAMS

National Institute of Arthritis and Musculoskeletal and Skin Diseases

Arthritis, musculoskeletal, and skin research; supports networks/registries.

NICHD

(Eunice Kennedy Shriver) National Institute of Child Health and Human Development

Child/maternal health, development, and reproduction; perinatology networks.

NIDCR

National Institute of Dental and Craniofacial Research

Dental/craniofacial research; clinical studies and data standards in dentistry.

NIDDK

National Institute of Diabetes and Digestive and Kidney Diseases

Diabetes, digestive, and kidney diseases; large cohorts and trials.

NIMH

National Institute of Mental Health

Mental health research; clinical trials, outcome measures, and data sharing.

NINDS

National Institute of Neurological Disorders and Stroke

Neurology and stroke research; funds natural-history and interventional studies.

NOFO

Notice of Funding Opportunity

Current term for public grant solicitations (e.g., NIH); describes scope, eligibility, and application instructions; supersedes “FOA.”

PA

Program Announcement

Broad NIH funding announcement used to encourage applications in a particular scientific area; typically reviewed in standard CSR study sections unless otherwise noted.

PAG

Patient Advocacy Group

Patient-voice partners in design, outcomes, recruitment, and dissemination.

PAR

Program Announcement Reviewed in an Institute

Type of NIH funding announcement; applications are reviewed by the sponsoring Institute/Center rather than CSR; often used for institute-specific initiatives.

PD

Permissions Dashboard

The RDCRN Permissions Dashboard website displays RDCRN member accounts and their permissions within the RDCRN suite of tools, websites and services.

PD

Protocol Deviation

Departure from the approved protocol, procedures, or GCP requirements; may be classified as minor or major per SOP; must be documented and reviewed. See also: CAPA.

PHI

Protected Health Information

Individually identifiable health information regulated by HIPAA; includes medical, demographic, and payment details linked to a person. Requires safeguards and often a BAA when shared with vendors. See also: PII.

PI

Principal Investigator

Leads study at site/network.